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Fidgety Movements in Cystic Fibrosis

NCT03381157 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2019-07-23

No results posted yet for this study

Summary

Very low birth weight infants who are at risk for chronic lung diseases may also be at risk for brain anomalies such as increased echogenicity, leukomalacia and intracranial hemorrhage. Infants with bronchopulmonary dysplasia have been reported to have worse neurodevelopmental outcomes than healthy infants. It has also been pointed out that babies with prolonged and recurrent apneas during sleep may have weak General Movements (GMs) repertoire.

It has been mentioned that motor development retardation may also occur in neurodevelopmental diseases, genetic diseases and chronic lung diseases, as well as in cystic fibrosis. In infants with cystic fibrosis, motor development may be affected by increased incidence of hospitalization, previous infections, malnutrition, respiratory and digestive system disorders. There is no research done with GMs assessment to determine motor dysfunction in infants with cystic fibrosis and this topic is open to research.

Having more information about the motor development of babies by determining the motor characteristics and motor performance of infants with cystic fibrosis, it may be possible to start the disease-specific physiotherapy and rehabilitation programs as early as possible. For this reasons, in the study the investigators aimed to investigate the characteristics of GMs in the "Fidgety" period of 3-5 month term infants diagnosed with cystic fibrosis, to determine the motor performances and to investigate the relation between the GMs characteristics and the features of the disease.

The hypotheses the investigators have set for this study are listed below;

Ho: Spontaneous movements of the "Fidgety" period of infants diagnosed with 3-5 months of cystic fibrosis are not different from normal infants.

H1: Spontaneous movements of "Fidgety" period of infants diagnosed with cystic fibrosis between 3-5 months are different from normal infants.

Conditions

Interventions

OTHER

Observational General Movements Assessments

GMs assessment has been increasingly used to predict motor dysfunction, especially the Cerebral Palsy (SP), since its introduction 25 years ago. The GMs assessment is based on the visual holistic perception of normal and abnormal movements of the body. This approach focuses on spontaneous movements of the baby rather than reflexes, tonus, and reactions

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Eligibility

Min Age
3 Months
Max Age
5 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2019-02-02
Completion
2019-02-02

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381157 on ClinicalTrials.gov